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In-office balloon dilation for baro-challenge-induced Eustachian tube dysfunction: study protocol for a randomized

Mohammad Aleinati1, Jennifer L Spiegel2,3,4, Trung N Le2,3

  • 1Section of Otolaryngology-Head and Neck Surgery, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

Trials
|June 18, 2026
PubMed
Summary

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Balloon dilation of the Eustachian tube (BDET) is being tested against a sham procedure for baro-challenge-induced Eustachian tube dysfunction (BCETD). This blinded, sham-controlled trial aims to provide high-quality evidence on BDET efficacy for BCETD symptoms.

Area of Science:

  • Otolaryngology
  • Medical Devices
  • Clinical Trials

Background:

  • Eustachian tube dysfunction (ETD) affects many individuals, with baro-challenge-induced ETD (BCETD) presenting unique diagnostic and therapeutic challenges.
  • Current evidence for balloon dilation of the Eustachian tube (BDET) in treating BCETD is limited, necessitating rigorous investigation.
  • The subjective nature of BCETD symptoms underscores the need for blinded, sham-controlled studies to ensure reliable outcome assessment.

Purpose of the Study:

  • To evaluate the efficacy of BDET compared to a sham procedure in alleviating symptoms of BCETD.
  • To test the hypothesis that BDET is superior to a sham intervention for BCETD symptom reduction.

Main Methods:

  • A randomized, sham-controlled, multicenter trial involving adults with BCETD who have failed conservative management.
Keywords:
Balloon Eustachian tuboplastyBalloon dilation of the Eustachian tubeBaro-challenge Eustachian tube dysfunctionBaro-challenge-induced Eustachian tube dysfunctionBarotitisBarotraumaEustachian tubeEustachian tube dilationEustachian tube dysfunctionRandomized clinical trial

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  • Participants will be randomized to undergo either BDET or a sham procedure in an office setting under local anesthesia.
  • Primary outcome is the change in BCETDQ-7 scores at 6 weeks; secondary outcomes include ETDQ-7, middle ear equalization ability, quality of life (EQ-5D-5L), and activity impairment, assessed up to 52 weeks.

    • Main Results:

    • This section will report the primary and secondary outcome results comparing BDET and sham procedures at various follow-up points.
    • Statistical analysis will determine if BDET shows a significant improvement in BCETD symptoms compared to the sham intervention.
    • Data on patient-reported outcomes, including symptom severity and quality of life, will be analyzed to assess treatment effectiveness.

    Conclusions:

    • BDET presents a potential minimally invasive option for BCETD patients refractory to medical treatment.
    • This study represents the first blinded, sham-controlled trial investigating BDET for BCETD, aiming to mitigate bias and enhance outcome reliability.
    • Positive findings could establish BDET as a novel therapeutic approach, addressing a significant unmet need in BCETD management.